A Phase 4 interventional study of Reinforced preventive ARV therapy in Mother to Child HIV Transmission, sponsored by ANRS, Emerging Infectious Diseases. Completed at 1 site in Guinea. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 4, Interventional, and Treatment
Principal objective Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth* among infants at high risk of infection with HIV** .
in a maximum of 48 hours after delivery
Intervention, a combined strategy :
After positive HIV infection screening from mother in the delivery room and put on antiretroviral treatment of mothers with post partum according to national guidelines , newborns benefit :
Objectives Principal objective Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth* among infants at high risk of infection with HIV** .
* in a maximum of 48 hours after delivery
**born from HIV infected mothers who received less than 4 weeks of antiretroviral therapy prior delivery and / or HIV infection diagnosed at delivery Secondary objectives
Methodology Prospective non-comparative study of mother-child pairs whose mother is HIV-infected and received less than 4 weeks of antiretroviral therapy before birth or whose HIV infection has been diagnosed at birth.
Estimated enrolment: 300 mother-child pairs
Eligibility:
Inclusion criteria:
Mother-child pairs whose mother is HIV-infected and received less than 4 weeks of antiretroviral therapy before delivery or whose HIV infection has been diagnosed at delivery Mother who signed the informed consent form to participate in the study.
non-inclusion criteria: Mother treated with antiretrovirals during the month preceding delivery No inclusion for precautionary reason : clinical symptoms suggesting an opportunistic infection of the central nervous system.
No inclusion for monitoring difficulties History or presence of allergy to the study drugs or their components Contra-indications to the study drugs Symptoms, physical signs or laboratory values suggestive of systemic disorders, (including renal, hepatic, cardiovascular, pulmonary, skin, or psychiatric and other conditions, which could interfere with the interpretation of the trial results
Intervention, a combined strategy :
After positive HIV infection screening from mother in the delivery room and put on antiretroviral treatment of mothers with post partum according to national guidelines , newborns benefit :
Exclusion Criteria:
The proposed reinforced preventive ARV Therapy will be administrated to all newborns exposed to HIV (zidovudine+lamivudine+nevirapine if the newborn is exposed to HIV-1 or HIV-1/2, zidovudine+lamivudine if the newborns exposed to HIV-2)
Drug: Reinforced preventive ARV therapy
If the mother is HIV-1 or HIV 1/2 infected: * zidovudine / laminvudine (60/30 mg), ¼ cp morning and evening orally for 12 weeks. * nevirapine: 15mg/OD if weight ≥ 2500g / 10mg/OD if weight = 2000-2499g / 2mg/kg/OD if weight \< 2000g for 12 weeks in case of HIV-1 infection. After 6 weeks, nevirapine will increase at 20mg/OD If the mother is HIV-2 infected: - zidovudine / laminvudine (60/30 mg), ¼ cp morning and evening orally for 12 weeks.
Also known as: Early diagnosis in children exposed to HIV
Proportion of newborns who have received an HIV diagnosis and reinforced preventive antiretroviral treatment at birth.
Proportion of newborns who have received both HIV test and reinforced preventive antiretroviral treatment in a maximum of 48 hours after birth.
Time frame: Day 2
Proportion of mothers diagnosed with HIV who will initiate an antiretroviral therapy
• Proportion of mothers diagnosed with HIV at Day 0 who will initiate an antiretroviral therapy
Time frame: Week 72
Proportion of children diagnosed with HIV who will initiate an antiretroviral therapy
• Proportion of children diagnosed with HIV from Day 0 to Week 72 who will initiate an antiretroviral therapy
Time frame: Week 72
Proportion of mother-child pairs retained in the study with child having 2 PCR performed after stopping reinforced preventive antiretroviral treatment
• Proportion of mother-child pairs retained in the study from Day 0 to Week 24 with child having 2 PCR performed after stopping reinforced preventive antiretroviral treatment
Time frame: Week 24
Proportion of mother-child pairs retained in the study
• Proportion of mother-child pairs retained in the study from Day 0 to Week 72.
Time frame: Week 72
Measure the clinical tolerance of reinforced preventive antiretroviral treatment in children
• Nature of clinical adverse events
Time frame: Week 12
Measure the biological tolerance of reinforced preventive antiretroviral treatment in children
• Nature of biological adverse events
Time frame: Week 12
Measure the proportion of children on reinforced preventive antiretroviral treatment with anemia
• Proportion of children with anemia superior or equal to grade 2
Time frame: Week 12
Measure the proportion of children who change antiretroviral therapy for grade 4 adverse event
• Proportion of children who change antiretroviral therapy for grade 4 adverse event
Time frame: Week 12
Measure the proportion of children with preventive antiretroviral treatment interruption
• Proportion of children with preventive antiretroviral treatment interruption
Time frame: Week 12
Describe the clinical events occurring in mothers
• Description of clinical events occurring in mothers
Time frame: Week 72
Measure the proportion of mothers presenting clinical events
• Proportion of mothers presenting clinical events
Time frame: Week 72
Describe the immunological outcomes in mothers
• Value of CD4 (absolute number)
Time frame: Week 72
Describe the virological outcomes in mothers
• Value of HIV RNA (copies/mL)
Time frame: Week 72
Describe the clinical outcomes in HIV-infected children
• Description of clinical events occurring in HIV-infected children
Time frame: Week 48
Measure the proportion of HIV-infected children presenting clinical events
• Proportion of HIV-infected children presenting clinical events
Time frame: Week 48
Describe the immunological outcomes in HIV infected children
• Value of CD4 (absolute number)
Time frame: Week 48
Describe the virological outcomes in HIV infected children
• Value of HIV RNA (copies/mL)
Time frame: Week 48
Describe the clinical outcomes in HIV-non-infected children
Nature of clinical events occurring in HIV-non-infected children
Time frame: Week 72
Measure the proportion of HIV-non-infected children presenting clinical events
• Proportion of HIV-non-infected children presenting clinical events
Time frame: Week 72
Describe the rate of mother to child transmission of HIV
• Proportion of HIV infected children (based on PCR ADN or ARN)
Time frame: Week 72
Describe the risk factors of mother to child transmission of HIV
Description of risk factors for HIV transmission
Time frame: week 72
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ANRS, Emerging Infectious Diseases